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NCT01987492 · ClinicalTrials.gov registry record · Phase 2
A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
NCT01987492 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 230 participants.
The verdict
NCT01987492, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
Study Summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.
Interventions
- DRUG Placebo
- DRUG Lebrikizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2014-02-28 |
| Est. Completion | 2016-12-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01987492
The ClinicalTrials.gov registry entry for NCT01987492 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01987492 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01987492 about?
NCT01987492 is a clinical study titled "A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma". This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/p...
What is the current status of trial NCT01987492?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2014-02-28. Estimated completion is 2016-12-20.
What interventions are being tested in trial NCT01987492?
The interventions under investigation include: Placebo (DRUG), Lebrikizumab (DRUG).
Who is sponsoring clinical trial NCT01987492?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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